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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
510(k) Number K822709
Device Name URITEST 9, INLAB REAGENT STRIPS URINALY
Applicant
Laprol Scientific, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Laprol Scientific, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1095
Classification Product Code
JMA  
Date Received09/07/1982
Decision Date 01/28/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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